Clinical trial · Interventional
Development and Evaluation of a Self-Management Model for Cancer Rehabilitation
A Randomized Controlled Clinical Trial on the Development and Evaluation of a Self-Management Model for Cancer Rehabilitation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Participants were primarily recruited from medical institutions, specifically targeting newly diagnosed patients with malignant tumors. They were randomly assigned to two different rehabilitation models using block randomization: the cancer self-help rehabilitation model or the conventional rehabilitation model. During the intervention period, trained oncology advanced practice nurses conducted weekly questionnaire surveys for enrolled patients. During the follow-up period, these surveys were conducted every four weeks. Peripheral venous blood samples were collected at baseline and at weeks 0, 4, 8, and 12 after the intervention began to test for biomarkers related to emotional distress.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Psychotherapy | — | UNRESOLVED | — |
| Rehabilitation | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional rehabilitation model | Other | — | UNRESOLVED |
| Self-help rehabilitation model | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Self-help rehabilitation model
- interventionNames
- Other: Self-help rehabilitation model
- type
- PLACEBO_COMPARATOR
- label
- Conventional rehabilitation model
- interventionNames
- Other: Conventional rehabilitation model
Primary outcomes (1)
- measure
- Degree of improvement in emotional distress
- timeFrame
- 16 weeks
- description
- After the intervention period for the patients, the change in the HADS (Hospital Anxiety and Depression Scale) total score was assessed based on the scoring criteria, comparing the scores to the baseline. The HADS scoring ranges are as follows: Total Score Range: 0 to 42； Anxiety Subscale (HADS-A): 0 to 21； Depression Subscale (HADS-D): 0 to 21； Score Interpretation: 0-7: Normal range, typically indicating no significant anxiety or depression symptoms.； 8-10: Mild anxiety or depression, may warrant monitoring; 11-14: Moderate anxiety or depression, further assessment or intervention is advisable; 15 and above: Severe anxiety or depression, usually requiring professional mental health intervention; In summary, higher scores on the HADS indicate more severe symptoms of anxiety or depression.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically diagnosed with head and neck malignancy. * Experiencing psychological distress. * Aged between 18 and 70 years. * Patients scheduled to receive antitumor treatment in a day hospital or outpatient setting. * ECOG performance status score of 0-2. * Patients voluntarily participate, fully understand, and are able to independently complete the questionnaires. Exclusion Criteria: * A history of other malignancies within the past 5 years. * A history of any mental illness, including but not limited to: generalized anxiety disorder, depressive disorder, panic disorder, schizophrenia, or bipolar disorder. * Patients currently receiving other psychological treatments or taking psychiatric medications.
References
Publications (0)
Data not yet available